Shortages Persist for Parenteral Nutrition

Patients scrambling for the at-home parenteral nutrition they rely on for survival have made the news in recent days, but it’s just another salvo in a decades-long struggle with supply.

“Shortages for parenteral nutrition are not new for clinicians,” Phil Ayers, PharmD, chief of clinical pharmacy services at Baptist Medical Center in Jackson, Mississippi, told MedPage Today.

In the mid-1980s, clinicians started to see a a shortage of multivitamin products, he noted. And since about 2010, there have been shortages of essentially every single ingredient.

Intravenous administration of nutrition is needed by a wide variety of patients — young and old, hospitalized and ambulatory — and for the gamut of nutrients from protein, carbohydrate, fat, minerals, and electrolytes to vitamins and other trace elements.

However, though life-saving for tens of thousands of patients who otherwise cannot eat or absorb enough food through tube feeding formula or by mouth to maintain good nutrition status long term as well as many more who may need it short-term, there continue to be shortages in parenteral nutrition.

“It’s something that we’ve been dealing with in the nutrition world for a number of years,” said Ayers, who is president-elect of the American Society for Parenteral and Enteral Nutrition (ASPEN). “It’s oftentimes hit or miss, and you have to be very nimble.”

That organization’s website details what’s currently in shortage and provides recommendations to help clinicians manage those shortages, including how to dose appropriately.

“Providing this therapy is particularly challenging for clinicians because PN [parenteral nutrition] is a complex medication and may contain 20 or more ingredients, of which multiple components may simultaneously be in limited supply,” the website notes. “The availability of PN components must be considered during every step of the PN use process from ordering the PN prescription to administering this therapy to a patient. Unlike antibiotics, there are no therapeutic alternatives for missing PN components.”

As of October 2022, parenteral components noted as in shortage by the FDA include amino acids and multivitamin infusion for adult and pediatric use as well as potassium chloride concentrate injection and sterile water.

The cause of these shortages range just as widely.

There can be regulatory issues or natural disasters that affect manufacturing plants, Ayers noted. Additionally, there have been voluntary recalls, issues with raw materials, the discontinuation of products by companies, and business decisions in favor of higher-profit manufacturing.

“We’re one supply line, one hurricane, or one other company decision not to make this [away from] life-threatening shortages,” agreed Paul Wischmeyer, MD, of Duke University School of Medicine and a member of the Society of Critical Care Medicine.

In 2017, for example, Hurricane Maria shut down key IV supply manufacturers in Puerto Rico. The pandemic caused system-wide shortages in parenteral nutrition primary ingredients. And last year, one of the largest providers, CVS Health, shuttered half of its Coram home infusion branches for home parenteral nutrition and “acute care” drugs such as IV antibiotics, refocusing on the more lucrative specialty IV medication market for autoimmune and other conditions. Another big supplier, Optum Rx, also consolidated its parenteral nutrition services in 2022.

Aside from the direct challenges that shortages lead to, Wischmeyer and others also noted that, whether it be a lack of availability of certain products, or lack of access to a local provider or supplier of parenteral nutrition where some may have left the market, hospitals can be left with patients who are ready to go home but cannot be discharged without at-home parenteral nutrition therapy arrangements.

“It’s a huge problem,” Wischmeyer said, calling for increasing medical education or subsequent training on clinical nutrition for physicians. Ayers also pointed to the importance of ongoing patient advocacy.

Amid ongoing shortages, the National Home Infusion Association (NHIA), which represents companies that provide therapies to patients as well as companies that manufacture and supply infusion related products and services, released a white paper outlining their findings on the issue.

“Shortages of PN [parenteral nutrition] ingredients and infusion-related disposable supplies resulted in substantial cost increases to infusion providers,” the report states in part. “This was the case during the peak pandemic years, and despite some relief within the supply chain, persistent inflationary pressures have extended cost increases to the present day.”

Connie Sullivan, CEO of the NHIA, pointed to one particular finding that the cumulative 5-year increase per bag of parenteral nutrition was about 50% over 2016 costs.

Sullivan told MedPage Today that there have been some companies that have reached a “tipping point,” having not been “paid enough to stay in business and serve patients the way they need to be served.”

Among the solutions put forward in the NHIA report is that payers consider the increased cost of items and services as they negotiate with providers to ensure payment reflects the complexity of care that is being provided.

“We need many providers offering services … if we don’t maintain that, we will have access issues,” Sullivan said.